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Investor Update

Basel, 16 September 2008

Avastin: only biologic to demonstrate significant survival benefit in first-line andsecond-line metastatic colorectal cancer patients

Data presented at the 33rd Congress of the European Society for Medical Oncology (ESMO) confirmed that Avastin in combination with chemotherapy is the only biologic that provides a statistically significant overall survival (OS) benefit to patients receiving first-line or second-line treatment for metastatic colorectal cancer (mCRC). In addition, Avastin remains the only biologic offering a progression-free survival (PFS) benefit regardless of mutations in the K-Ras gene, and also the only biologic with a statistically significant OS benefit in K-Ras wild-type patients.

Several studies demonstrate benefit in first-line mCRC

At ESMO, an update of the independent CAIRO-2 study, which compared Avastin + chemotherapy (XELOX) versus Avastin + chemotherapy + cetuximab (Erbitux) in first-line treatment of mCRC was presented. The study showed that:

  • Patients treated with Avastin and chemotherapy lived longer without their disease worsening compared to those treated with cetuximab, Avastin and chemotherapy (median PFS = 10.7 months vs. 9.4 months; p=0.013). Thus, Avastin plus chemotherapy again demonstrated an unsurpassed PFS of above 10 months in this patient population.
  • Patients in the cetuximab (Erbitux)-containing arm had an approximately 10% higher incidence of serious side effects, which was attributed to cetuximab-related skin toxicity.
  • The addition of cetuximab (Erbitux) did not add any survival benefit (median OS 20.3 months for XELOX+Avastin vs. 19.4 months for XELOX+Avastin+cetuximab, p=0.16).

This confirmed findings from the randomized, placebo-controlled AVF2107 study of Avastin in first-line mCRC demonstrating that:

  • Avastin provides a statistically significant gain in OS in the general, unselected population (20.3 vs. 15.6 months in the Avastin and control arm respectively) (hazard ratio: 0.66, p<0.001).
  • Avastin provides a statistically significant OS advantage in the K-Ras wild-type population  (27.7 vs. 17.6 months in the Avastin and Control arm respectively) (HR 0.58, p=0.04)
  • Avastin also provides statistically significant improvements in the time patients live without their disease worsening for both K-Ras wild-type (PFS improved by 82%, from 7.4 to 13.5 months, hazard ratio: 0.44, p<0.0001) and K-Ras mutant patients (PFS improved by 69%, from 5.5 to 9.4 months, hazard ratio: 0.41, p=0.0008).

Overall survival reported from First BEAT and BRiTE

At ESMO, the overall survival benefit of Avastin has been confirmed in two large community-based studies (First BEAT / BRiTE), which combined Avastin with commonly used chemotherapies in mCRC and included some 4,000 patients. The studies demonstrate that Avastin-based therapy provides a median overall survival benefit for patients of approximately two years (23.5 and 22.7 months from BRiTE and First BEAT respectively). The BriTE study further shows that long-term Avastin treatment did not increase the risk of patients suffering from Avastin-specific side effects, which were consistent with those reported in other clinical trials.

Avastin: only biologic with significant survival benefit also in second-line mCRC

The ESMO congress further confirmed that Avastin remains the only biologic with a proven survival benefit in second-line treatment of mCRC. In second-line mCRC, the pivotal E3200 study showed a statistically significant improvement in OS from 10.8 to 12.9 months (HR: 0.75 ; p=0.001) for Avastin plus oxaliplatin-based chemotherapy over chemotherapy alone.

In January 2008, Avastin received a broad label in the EU allowing it to be used in combination with fluoropyrimidine-based chemotherapy for first and later treatment lines in patients with mCRC. This means that virtually all patients with metastatic colorectal cancer have access to Avastin’s benefits.

About Avastin

Avastin directly inhibits vascular endothelial growth factor (VEGF), a key mediator of angiogenesis (the growth of new blood vessels). Blocking tumor angiogenesis with Avastin starves the tumor of the blood supply that is critical for its growth and spread throughout the body (metastasis). Because Avastin directly blocks tumor angiogenesis, a process common to all types of tumor development, it has the potential to deliver patient survival benefits in a variety of different cancer types. Roche is therefore pursuing a comprehensive clinical trial program investigating the use of Avastin in over 20 tumor types and different settings (advanced, post surgical).

The total development program is expected to include over 40,000 patients world-wide and has already resulted in approvals in advanced colorectal, breast, lung, and renal cell cancer.

  • February 2004 (US) and January 2005 (EU) – first-line treatment in patients with metastatic colorectal cancer (CRC)
  • June 2006 (US) – second-line treatment in patients with metastatic CRC
  • October 2006 (US) and August 2007 (EU) – first-line treatment in patients with advanced non-small cell lung cancer
  • March 2007 (EU) – first-line treatment in patients with metastatic breast cancer (BC)
  • April 2007 (Japan) – treatment in patients with recurrent or advanced CRC
  • December 2007 (EU) – first-line treatment in patients with advanced renal cell cancer
  • January 2008 (EU) – first and later-line treatment in patients with metastatic CRC in combination with any chemotherapy
  • February 2008 (US) – first-line treatment in patients with HER-2 negative metastatic BC

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.

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